Devices and methods for enhancing immunogenicity to intradermal vaccination

Abstract

Devices and methods that utilize an occlusive dressing in combination with a topical pharmaceutical agent to enhance vaccine efficacy are described. The occlusive dressing delivers a defined dose of a topical pharmaceutical agent that enhances immune system reactivity to a vaccine to the site of vaccination, and provides a barrier that maintains a layer of the topical pharmaceutical agent on the skin for a desired period to time while also providing a port through which an immunizing composition can be administered. In some embodiments the occlusive dressing includes a wound dressing for covering the injection site following vaccination.

What is claimed is:  
     
       1. A method of applying a topical medication, comprising:
 (i) providing an occlusive device comprising a barrier layer, wherein the barrier layer comprises a central aperture and a first surface, wherein the central aperture extends through the first surface, wherein the occlusive device further comprises a frame that is affixed to a second surface of the barrier layer, wherein the second surface is opposite to the first surface of the barrier layer, wherein the frame comprises a frame aperture that is in central alignment with the central aperture of the barrier layer, and wherein the first surface comprises an amount of the topical medication; and 
 (ii) affixing the occlusive device to an area of the skin of an individual in need of treatment, wherein the first surface is in contact with the skin, and wherein the topical medication on the first surface is in contact with the skin, 
 wherein the central aperture of the occlusive device is included therein prior to affixing the occlusive device to the skin, and wherein at least a portion of the area of the skin is exposed through the central aperture. 
 
     
     
       2. The method of  claim 1 , wherein the topical medication is applied using an applicator configured to deliver a fixed volume of the topical medication. 
     
     
       3. The method of  claim 2 , wherein the fixed volume is from 25 μL to 4 mL. 
     
     
       4. The method of  claim 1 , wherein the topical medication comprises an immunization enhancer. 
     
     
       5. The method of  claim 4 , wherein the topical medication comprises a squalene. 
     
     
       6. The method of  claim 4 , wherein the topical medication comprises a toll like receptor agonist. 
     
     
       7. The method of  claim 1 , further comprising the step of administering a pharmaceutical formulation through the central aperture by injection. 
     
     
       8. The method of  claim 7 , wherein the pharmaceutical formulation is a vaccine formulation. 
     
     
       9. The method of  claim 1 , wherein the method further comprises (a) applying the amount of the topical medication to the first surface prior to, during, or after step (i) and prior to step (ii). 
     
     
       10. A method of applying a topical medication, comprising:
 providing an occlusive device comprising a barrier layer, wherein the barrier layer comprises a central aperture and a first surface, wherein the central aperture extends through the first surface, wherein the occlusive device further comprises a frame that is affixed to a second surface of the barrier layer, wherein the second surface is opposite to the first surface of the barrier layer, and wherein the frame comprises a frame aperture that is in central alignment with the central aperture of the barrier layer; 
 applying an amount of the topical medication to an area of the skin of an individual in need of treatment; and 
 affixing the occlusive device to the area of the skin, wherein the first surface is in contact with the skin, 
 wherein the topical medication is applied to the area of the skin prior to affixing the occlusive device thereto, and wherein the topical medication is an immunization enhancer. 
 
     
     
       11. The method of  claim 10 , wherein the topical medication is applied using an applicator configured to deliver a fixed volume of the topical medication. 
     
     
       12. The method of  claim 11 , wherein the fixed volume is from 25 μL to 4 mL. 
     
     
       13. The method of  claim 10 , wherein the topical medication comprises a squalene. 
     
     
       14. The method of  claim 10 , wherein the topical medication comprises a toll like receptor agonist. 
     
     
       15. The method of  claim 10 , further comprising the step of administering a pharmaceutical formulation through the central aperture by injection. 
     
     
       16. The method of  claim 15 , wherein the pharmaceutical formulation is a vaccine formulation.